FDA Drug Chief Resigns Amid Explosive Defamation Lawsuit

BREAKING: Dr. George F. Tidmarsh, the head of the FDA’s drug division, resigned on November 2, 2025, just one day before being named in a federal defamation lawsuit by Aurinia Pharmaceuticals. The explosive lawsuit, filed in Maryland, alleges that Tidmarsh used his official position to settle personal scores, impacting the pharmaceutical industry significantly.

The allegations against Tidmarsh raise urgent questions about the integrity of the FDA and its ability to operate free from personal vendettas and conflicts of interest. This scandal could shake public trust in the agency, which oversees the safety and efficacy of over 20,000 approved drugs.

According to the lawsuit, Tidmarsh, who assumed leadership of the FDA’s Center for Drug Evaluation and Research in July, was placed on administrative leave shortly before his resignation as the Department of Health and Human Services (HHS) initiated an internal ethics investigation. HHS spokesperson Emily Hilliard stated, “Secretary Robert F. Kennedy expects the highest ethical standards from all individuals serving under his leadership.”

The 32-page complaint against Tidmarsh claims he made “false and defamatory statements” about Aurinia’s lupus nephritis treatment, Lupkynis, in a now-deleted LinkedIn post. The post alleged that the drug “has not been shown to provide a direct clinical benefit for patients,” contradicting the FDA’s own approval findings from 2021. Aurinia argues that Tidmarsh’s remarks triggered a 20 percent drop in their stock, erasing over $350 million in market value.

“We stand behind the favorable benefit/risk profile of Lupkynis,” Aurinia stated.

The lawsuit connects Tidmarsh’s actions to a broader pattern of alleged retaliation against Kevin Tang, Aurinia’s board chair. Tang previously urged Tidmarsh to resign from three other companies where he was a director. Text messages cited in the complaint reveal Tidmarsh’s threats of revenge, including a chilling message stating, “The pain is not over.”

Moreover, the lawsuit accuses Tidmarsh of attempting to solicit a bribe from American Laboratories, a company chaired by Tang. This occurred after the FDA announced enforcement actions against unapproved thyroid products, which Aurinia claims Tidmarsh targeted shortly after taking office.

In a statement, Tidmarsh has denied all allegations, asserting, “I gave up everything to go into government… I pursued the thyroid medications because they were marketed without FDA approval.”

As the lawsuit progresses, the HHS inspector general is reviewing Tidmarsh’s conduct, signaling a potential increase in scrutiny over both Tidmarsh and FDA operations. The FDA’s credibility is under the spotlight, emphasizing the need for transparency and accountability in its regulatory processes.

The implications of this lawsuit extend beyond Tidmarsh’s personal reputation; they highlight critical concerns about the FDA’s independence and the potential for personal biases to influence public health decisions. As this situation unfolds, all eyes will be on the FDA and the outcomes of the ongoing investigation.

Stay tuned for more updates as this story develops, with significant ramifications for both the pharmaceutical industry and public health oversight.